FDA Priority Review of Lykos Therapeutics' New Drug Application: A Landmark in Psychedelic-Assisted Therapy

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Dr. Jessica Nelson
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FDA Priority Review of Lykos Therapeutics' New Drug Application: A Landmark in Psychedelic-Assisted Therapy

A Historic Milestone in Mental Health Treatment

In a landmark development, the U.S. Food and Drug Administration (FDA) has accepted and granted Priority Review to the first New Drug Application (NDA) for a psychedelic-assisted therapy. The application, submitted by Lykos Therapeutics, is for midomafetamine capsules MDMA, used in combination with psychological intervention for individuals suffering from post-traumatic stress disorder (PTSD). The FDA has set a target action date of August 11, 2024, for its decision on the application. This groundbreaking achievement signifies a shift in the landscape of mental health treatment and represents the dedication and collaborative efforts of the Lykos team and their partners.

Addressing the PTSD Crisis

PTSD affects approximately 13 million Americans each year and has a substantial economic impact. The disorder is more prevalent among women, disadvantaged or marginalized groups, and military personnel. However, the largest cause of PTSD is non-combat related trauma. Despite the magnitude of this issue, the first-line treatment for PTSD remains trauma-focused talk therapy and there have been no new drug treatments approved by the FDA in over twenty years. Lykos Therapeutics' innovative MDMA-assisted therapy could potentially fill this void.

About the MDMA-Assisted Therapy

MDMA-assisted therapy involves the use of MDMA in combination with intentional therapy. The NDA submission by Lykos Therapeutics included results from two randomized double-blind placebo-controlled Phase 3 studies, which met their primary and secondary endpoints. The studies showed promising results and were published in Nature Medicine.

MDMA's Potential Medical Use

MDMA is being studied as an investigational modality for the treatment of PTSD. In 2017, the FDA granted the company's investigational MDMA-assisted therapy Breakthrough Therapy designation, recognizing its potential medical use. The therapy is also being studied for other indications.

Support from MAPS

The NDA application was supported by clinical trial data collected over two decades of research incubated by the Multidisciplinary Association for Psychedelic Studies (MAPS). MAPS has congratulated Lykos Therapeutics on this achievement, expressing hope for potential FDA approval of MDMA-assisted therapy for PTSD.

Implications for the Future of Mental Health Treatment

The acceptance of Lykos Therapeutics' application by the FDA not only signals a significant leap in mental health treatment but also provides a substantial boost to the legitimacy of psychedelic therapies. It expands treatment options for PTSD and emphasizes the FDA's commitment to ensuring the safety and efficacy of psychedelic treatments. The development also paves the way for collaboration and training programs to meet the demand for responsible and safe MDMA-assisted therapy.